JP6434267B2 - カプセル剤 - Google Patents
カプセル剤 Download PDFInfo
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- JP6434267B2 JP6434267B2 JP2014200803A JP2014200803A JP6434267B2 JP 6434267 B2 JP6434267 B2 JP 6434267B2 JP 2014200803 A JP2014200803 A JP 2014200803A JP 2014200803 A JP2014200803 A JP 2014200803A JP 6434267 B2 JP6434267 B2 JP 6434267B2
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- capsule
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- gelatin
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- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
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- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
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- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
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Description
項1. (A)アントシアニン、プロアントシアニジン、プロシアニジン及びカテキンよりなる群から選択される少なくとも1種のポリフェノール、並びに(B)大豆イソフラボン及び/又はその代謝産物を含む内容物が、
ゼラチンを含むカプセル皮膜からなるカプセルに充填されている、
ことを特徴とする、カプセル剤。
項2. 前記(A)成分の総量100重量部当たり、前記(B)成分を総量で2.5〜250重量部含む、項1に記載のカプセル剤。
項3. 前記内容物が、更に(C)油性基剤、及び(D)界面活性剤を含む、項1又は2に記載のカプセル剤。
項4. 前記(A)成分が、フルーツ及び/又は茶葉由来である、項1〜3のいずれかに記載のカプセル剤。
項5. 前記(B)成分が、エクオールである、項1〜4のいずれかに記載のカプセル剤。
項6. ソフトカプセル剤である、項1〜5のいずれかに記載のカプセル剤。
項7. ゼラチンを含むカプセル皮膜からなるカプセルに充填する内容物中で、(A)アントシアニン、プロアントシアニジン、プロシアニジン及びカテキンよりなる群から選択される少なくとも1種のポリフェノールと(B)大豆イソフラボン及び/又はその代謝産物を共存させることを特徴とする、カプセルの硬化抑制方法。
[(A)特定のポリフェノール]
本発明のカプセル剤に充填される内容物は、アントシアニン、プロアントシアニジン、プロシアニジン、及びカテキンよりなる群から選択される少なくとも1種のポリフェノールを含む。これらの特定のポリフェノールは、ゼラチンを含むカプセル皮膜を経時的に硬化させる作用があるが、本発明では、後述する(B)成分を併用することによって、当該カプセル皮膜の経時的な硬化を抑制することが可能になる。
本発明のカプセル剤に充填される内容物は、前記特定のポリフェノールと共に、大豆イソフラボン及び/又はその代謝産物を含有する。このように大豆イソフラボン及び/又はその代謝産物を含有することにより、前記特定のポリフェノールによって生じるカプセル皮膜の経時的な硬化を抑制することが可能になる。
本発明のカプセル剤に充填される内容物には、前記(A)及び(B)成分以外に、必要に応じて、油性基剤((C)成分)が含まれていてもよい。このような油性基剤を含有することによって、より一層効果的にゼラチンを含むカプセル皮膜の経時的な硬化等の性状変化を抑制することが可能になる。
本発明のカプセル剤に充填される内容物には、前記(A)及び(B)成分以外に、必要に応じて、界面活性剤((D)成分)が含まれていてもよい。特に、当該内容物に前記油性基剤を含有させる場合には、前記(A)及び(B)成分の分散性を向上させるために、界面活性剤を含んでいることが好ましい。
本発明のカプセル剤に充填される内容物には、前記(A)〜(D)成分以外に、必要に応じて、他の栄養成分や薬理成分を含有していてもよい。このような栄養成分や薬理成分としては、食品や医薬品に使用可能なものであれば特に制限されないが、例えば、ビタミンB1、ビタミンB2、ビタミンB6、ビタミンB12、ビタミンC、ビタミンA、ビタミンD、ビタミンE、ビタミンK、ナイアシン、パントテン酸、葉酸、ビオチン、リコペン等のビタミン類;塩酸ベタイン、塩化ベタネコール等の健胃剤;アクリノール、塩化ベルベリン、クレオソート、タンニン酸、臭化水素酸スコポラミン、臭化メチルアトロピン、塩酸パパベリン、アミノ安息香酸エチル等の止瀉剤;塩酸イソチベンジル、塩酸ジフェニルピラリン、塩酸ジフェンヒドラミン、マレイン酸クロルフェニラミン、酒石酸アリメマジン等の抗ヒスタミン剤;臭化水素酸デキストロメトルファン、ヒベンズ酸チペピジン、リン酸ジヒドロコデイン等の鎮咳剤;カルシウム、イオウ、マグネシウム、亜鉛、セレン、鉄等のミネラル類;大豆タンパク、卵白粉末、乳清タンパク等のタンパク質;グリシン、アラニン、アルギニン、アスパラギン酸、シスチン、フェニルアラニン、タウリン、トリプトファン等のアミノ酸;ショ糖、果糖、乳糖、水アメ、果糖ブドウ糖液糖、スクラロース、ソーマチン、アスパルテーム、アセスルファムK、オリゴ糖(例えば、マルトオリゴ糖、イソマルトオリゴ糖、ガラクトオリゴ糖、イヌロオリゴ糖、フラクトオリゴ糖、キシロオリゴ糖)、ポリデキストロース、デキストリン、難消化性デキストリン、還元難消化性デキストリン等の甘味料;リノール酸、γ−リノレン酸、α−リノレン酸等の脂肪酸類;アガリクス、シイタケ、レイシ、ヤマブシタケ等のキノコ類又はそのエキス;食物繊維、ローヤルゼリー、プロポリス、ハチミツ、コンドロイチン硫酸、グルコサミン、セラミド、ヒアルロン酸等のその他機能性素材等が挙げられる。これらの添加成分は、1種単独で使用してもよく、また2種以上を組み合わせて使用してもよい。また、これらの添加成分の含有量については、使用する添加成分の種類等に応じて適宜設定される。
本発明のカプセル剤に充填される内容物の形態については、特に制限されず、液状、固形状、半固形状(ゲル状、クリーム状、ペースト状)等のいずれであってもよいが、好ましくは半固形状、更に好ましくはクリーム状が挙げられる。
本発明のカプセル剤では、ゼラチンを含むカプセル皮膜からなるカプセルを用いて、前記内容物が充填される。
本発明のカプセル剤は、前記(A)成分に基づいて、抗酸化、眼精疲労回復、殺菌、血糖値抑制、LDLコレステロール低下、抗癌、血流改善、抗動脈硬化等の有益な作用を発揮できる。更に、本発明は、前記(B)成分に基づいて、更年期障害、骨粗鬆症、動脈硬化、心筋梗塞、乳がん、前立腺がんの予防や改善、動脈硬化等の疾患や症状の予防又は治療作用の他、女性ホルモンのバランス改善作用を発揮できる。従って、本発明は、医薬品の他、サプリメント、機能性食品、健康保健用食品、病者用食品等の食品としても提供することができる。
本発明のカプセル剤は、前記(A)及び(B)成分、必要に応じて(C)成分、(D)成分、他の添加成分を混合して、所望の形態にした内容物を調製し、当該内容物を、ゼラチンを含むカプセル皮膜からなるカプセルに充填することによって製造することができる。
前述するように、前記(B)成分には、ゼラチンを含むカプセル皮膜からなるカプセルに前記(A)成分を含む内容物を充填した際に生じるカプセルの経時的な硬化を抑制する作用がある。従って、本発明は、更に、ゼラチンを含むカプセル皮膜からなるカプセルに充填する内容物中で、(A)アントシアニン、プロアントシアニジン、プロシアニジン及びカテキンよりなる群から選択される少なくとも1種のポリフェノールと(B)大豆イソフラボン及び/又はその代謝産物を共存させることを特徴とする、カプセルの硬化抑制方法を提供する。
ブルーベリーカンソウエキス:ブルーベリーからポリフェノールを抽出した粉末状抽出物;アントシアニン35重量%含有;インデナジャパン株式会社製)
フルーツポリフェノール:リンゴ、ぶどう等のフルーツからポリフェノールを抽出した粉末状抽出物の混合物;アントシアニン及びりんごポリフェノールの合計量100重量%;ネキシラジャパン株式会社製)
緑茶抽出エキス:緑茶の茶葉からカテキンを抽出した粉末状抽出物;カテキン40重量%含有;丸善製薬株式会社製)
大豆抽出エキス:大豆からイソフラボンを抽出した粉末状抽出物;大豆イソフラボン40重量%含有;日本新薬株式会社製)
大豆胚芽発酵物:大豆胚芽を発酵させた発酵物の粉末;エクオール5重量%含有、大豆イソフラボンは含まれていない;株式会社ダイセル製)
表1及び2に示す組成のクリーム状の内容物を調製し、ゼラチンを含むカプセル皮膜に及ぼす影響を試験した。具体的には、水20gとグリセリン4gを混合して80℃に加温し、その後ゼラチン10gを添加してゼラチンが溶解するまで緩やかに撹拌し、ゼラチン溶液を調製した。このゼラチン溶液をシャーレに5mmの厚さになるように滴下し、室温で24時間乾燥させることにより、ゼラチンシート(直径10cmの円盤状)を作製した。また、別途、表1及び2に示す所定量のサフラワー油、グリセリン脂肪酸エステル、及びミツロウを加温しながら撹拌し、これらが溶解した後に撹拌しながら冷却し、油性基剤と界面活性剤の混合物を得た。この混合物に、他の添加成分を添加して撹拌することにより、クリーム状の内容物を調製した。
(ゼラチンシートの硬化抑制効果の判定基準)
◎◎:硬化上昇率が150%未満
◎:硬化上昇率が150%以上200%未満
○:硬化上昇率が200%以上250%未満
△:硬化上昇率が250%以上300%未満
×:硬化上昇率が300%以上
表3〜6に示す組成の内容物(1カプセル当たり300mg)を、ゼラチンを含むカプセル皮膜で被包したソフトカプセル剤を製造した。具体的には、表3〜6に示す所定量のサフラワー油、グリセリン脂肪酸エステル、及びミツロウを加温しながら撹拌し、これらが溶解した後に撹拌しながら冷却し、油性基剤と界面活性剤の混合物を得た。この混合物に、他の添加成分を添加して撹拌することにより、クリーム状の内容物を調製した。ソフトカプセル剤の一般的な製法に従って、得られた内容物300mgを、カプセル皮膜(1カプセル当たりゼラチン100mg及びグリセリン50mg含有)で被包し、ソフトカプセル剤を製造した。得られた各ソフトカプセル剤は、いずれもカプセル皮膜の経時的な硬化が抑制されており、優れた保存安定性を備えていた。
Claims (5)
- (A)アントシアニン、プロアントシアニジン、プロシアニジン及びカテキンよりなる群から選択される少なくとも1種のポリフェノール、並びに(B)エクオールを含む内容物が、
ゼラチンを含むカプセル皮膜からなるカプセルに充填されている、
ことを特徴とする、カプセル剤。 - 前記(A)成分の総量100重量部当たり、前記(B)成分を2.5〜250重量部含む、請求項1に記載のカプセル剤。
- 前記内容物が、更に(C)油性基剤、及び(D)界面活性剤を含む、請求項1又は2に記載のカプセル剤。
- 前記(A)成分が、フルーツ及び/又は茶葉由来である、請求項1〜3のいずれかに記載のカプセル剤。
- ソフトカプセル剤である、請求項1〜4のいずれかに記載のカプセル剤。
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